Electronic Data Capture (EDC)

In the dynamic clinical trial landscape, seamless data management is crucial for ensuring the success of research endeavors. Biotrial, a leading CRO, offers comprehensive Electronic Data Capture (EDC) solutions to streamline data collection and accelerate clinical trial timelines.

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Our experienced project teams specialize in setting up eCRF (electronic case report form) applications and in managing external high-quality EDC data. We leverage industry-leading EDC platforms, including Medidata Rave and Clincase, to capture and manage clinical trial data with precision and efficiency. These user-friendly tools offer a range of functionalities, including:

  • Custom Reporting: Generate comprehensive reports tailored to specific study requirements.
  • Pharmacovigilance Reporting: Effectively manage and track safety data throughout the clinical trial process.
  • Randomization and Drug Supply: Ensure randomization integrity and streamline drug supply management.
  • Risk-Based and Targeted Monitoring: Implement risk-based monitoring strategies and targeted data reviews for enhanced data quality.
Biotrial’s EDC team has the expertise to evaluate a wide variety of EDC systems and is available to advise sponsors on the best solution.

Tools

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Rave is the EDC industry leader and as such Biotrial has begun to implement this on clinical trials starting in 2015. Rave has been set up and managed by our Data Management group on numerous types of trials since then.

This collaboration allows sponsors to access the industry leading software in the hands of Biotrial’s expert team.

With extensive Biometrics experience in all Clinical Phases, we have been working with Clincase® since 2009. Sponsors appreciate Clincase® for its ergonomic design and positive site user feedback. Clincase is a cost effective and regulatory compliant (21CFR Part 11) software.

Randomization

Biotrial’s comprehensive randomization services encompass both local and central randomization strategies for clinical trials. Our centralized randomization services seamlessly integrate with a trial’s EDC platform, leveraging adapted software solutions for streamlined data capture and management.

Our dedicated Biostatistics team comprises expert Randomization Managers who oversee central randomization throughout the protocol’s lifecycle. These professionals work closely with statisticians to facilitate randomization list editing and optimize randomization schemes, ensuring the integrity of clinical trial data.

e-PRO

Biotrial’s e-PRO solutions empower sponsors and clinical site staff to collect and manage patient-reported outcomes (PROs) efficiently and effectively. Our comprehensive services range from full-service implementations to BYOD (Bring Your Own Device) options, ensuring the best-adapted solution for each clinical trial.

Whether you need to capture patient diaries, monitor compliance, or gather complex clinical scores, Biotrial’s e-PRO solutions provide a user-friendly and secure platform for data collection. Our experienced team will work closely with you to design and implement a solution that meets your study-specific requirements and regulatory standards.

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Our e-PRO solutions offer a range of benefits, including:

  • Improved data quality and timeliness: Electronic data capture (EDC) eliminates errors associated with paper-based methods, ensuring accurate and timely data collection.
  • Enhanced patient engagement: Patients can complete questionnaires and assessments from the comfort of their own homes, reducing their burden and improving compliance.
  • Streamlined data management: Our e-PRO solutions integrate seamlessly with existing clinical trial management systems (CTMS), simplifying data analysis and reporting.
  • Reduced costs: Electronic data capture eliminates the need for paper forms, printing, and manual data entry, saving time and money.

OUR team

Our team is composed of experts who possess in-depth knowledge of electronic data capture (EDC) technology and patient-reported outcomes (PROs). Each member is committed to providing our biotech and pharmaceutical clients with the highest quality of service and ensuring the success of their clinical trial studies.

Study Builder

They have a deep understanding of EDC workflows and can seamlessly integrate e-PRO solutions into existing clinical trial management systems (CTMS).

DM Project Leader

Serves as the central point of contact for all EDC-related activities throughout the clinical trial lifecycle. They possess extensive knowledge of global regulatory requirements and ensure that our e-PRO solutions meet the highest standards of compliance.

Services Solution Manager

Responsible for assessing the feasibility and implementation of trial. They work closely with clients to understand their unique needs and develop customized solutions that align with their research objectives.

Randomization Manager

independent member of the team with oversight of all randomization activities, ensuring the integrity of randomization processes in clinical trials.

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